MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANC ID TEST KIT

Catalog Number	21347
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
A customer in the united states contacted biomérieux to report a misidentification of cap survey strain clostridium septicum as clostridium clostridiforme in association with the vitek® 2 anaerobic and corynebacteria (anc) identification (id) test kit.Upon the advice of biomérieux support personnel, the customer repeated testing using a second swab; the expected cap id of clostridium septicum was obtained.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey strain.Biomérieux investigation will be conducted.
Additional Manufacturer Narrative
A customer from the united states reported to biomérieux a misidentification of a clostridium septicum cap survey sample as clostridium clostridioforme in association with the vitek® 2 anc test kit.An investigation was performed.The biomérieux internal lyophilized cap sample d-04 was reconstituted and subbed onto anaerobic cdc agar, which was incubated under anaerobic conditions for 24 hours, and tested on three different vitek® 2 anc lots.Vitek® ms testing was also performed.All three card lots tested obtained an excellent id (99%) of c.Septicum.The vitek® ms also identified the organism as c.Septicum, with a 99.9% confidence value.When customer lab reports with the incorrect ids of c.Clostridioforme were examined, it was noted that a "gram negative" result was entered for offline testing instead of "gram positive".This resulted in c.Clostridioforme being identified instead of c.Septicum.In some of these cases, there was also one atypical negative result (bdfuc) when compared to expected reaction results for c.Septicum.In conclusion the vitek® 2 anc test kit.Performed as expected and no further action is necessary.

• Brand Name: VITEK® 2 ANC ID TEST KIT
• Common Device Name: VITEK® 2 ANC ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 6605333
• Report Number: 1950204-2017-00175
• Device Sequence Number: 16416261
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440082403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1